On July 26, 2024, the Federal Trade Commission (FTC) announced its finalization of the updated Ophthalmic Practice Rules, commonly known as the Eyeglass Rule, found in 16 CFR Part 456. This update comes as a response to ongoing issues with prescribers not automatically providing patients with their eye prescriptions after exams. The FTC believes that an automatic-release rule, paired with mandatory documentation, is the most effective way to address this issue.

Here are the main takeaways from the updated Eyeglass Rule:

1. Immediate Prescription Release: Ophthalmologists and optometrists are now required to provide patients with a copy of their prescription immediately following a refractive eye exam, before offering to sell any ophthalmic goods, regardless of whether the patient requests the prescription.
2. Payment Policies: Prescribers may require payment for the refractive eye exam before providing the prescription, but only if they would have demanded immediate payment even if no ophthalmic goods were needed. Presenting proof of insurance is considered equivalent to payment.
3. Unconditional Exams: The availability of a refractive eye exam cannot be contingent upon the patient agreeing to purchase ophthalmic goods from the provider.
4. No Additional Fees or Liability Waivers: Prescribers cannot charge extra fees for providing the prescription, nor can they require patients to waive liability for the accuracy of the exam.
5. Definition of Prescription: A “prescription” includes all information required by state law. Currently, only Kansas, Massachusetts, Alaska, and New Mexico mandate the inclusion of pupillary distance (PD) in prescriptions. In other states, prescribers are not required to include PD in the prescription provided after the exam.
6. Digital Prescriptions: If a prescription is delivered digitally, prescribers must specify how it will be made available (via text, email, or portal) and ensure it is downloadable and printable. Before sending a digital prescription, prescribers must obtain verifiable and affirmative consent from the patient and retain this consent for three years, along with evidence of the prescription’s delivery.
7. Paper Prescriptions: When providing a paper copy, prescribers must have patients acknowledge receipt of the prescription, and this acknowledgment must be retained for three years. The FTC offers sample language for this acknowledgment, such as: “My eye care professional provided me with a copy of my prescription at the completion of my examination.”
8. Refusal to Acknowledge: If a patient refuses to sign a confirmation of receipt, the prescriber must note the refusal and sign it themselves.
9. Exemptions for Certain Prescribers: Prescribers without any financial interest in the sale of eyewear, whether direct or indirect, are exempt from the requirements regarding additional fees, digital prescriptions, and PD inclusion.

These changes aim to ensure that patients receive their prescriptions promptly and transparently, empowering them to make informed decisions about their eye care and eyewear purchases. The FTC continues to emphasize the importance of patient rights and access to medical information, advocating for consumer protection and fair practices in the ophthalmic industry.  The rule is expected to take effect in September 2024.

To read the final rule, click here.

 

August 19, 2024
By: Karen Perry, OD FAAO
Director Professional Relations, Government Regulation and HIPAA Compliance Privacy Officer